MAFAR4300 Development and Manufacturing of Medicinal Products Course description

This course concerns preclinical aspects of the development and manufacturing of medicinal products, with a particular focus on biological drugs and radiopharmaceuticals, which the pharmaceutical industry must consider before a pharmaceutical product becomes available to the user. Important topics include the choice of lead compounds, mode of action, choice of formulation and documentation of pharmaceutical quality.  

The student must have been admitted to the study programme.

After completing the course, the student should have the following overall learning outcomes defined in terms of knowledge, skills and general competence:

Knowledge

The student

• can explain the structural elucidation and structure-activity relationship of various pharmaceutical candidates
• can discuss especially expedient production and formulation strategies for biologics and radiopharmaceuticals
• can explain relevant analytical methods and molecular engineering used in the development and production of biological drugs
• can explain the requirements that apply to documentation of pharmaceutical quality (FDA/EMA) in connection with  a marketing authorisation application

Skills

The student

• can critically assess and apply new knowledge about the structure-activity relationship of pharmaceuticals to develop new medicinal products
• can apply relevant legislation on quality assurance of the manufacturing, storage and distribution of medicinal products, with particular emphasis on biological drugs and radiopharmaceuticals
• can identify and elucidate the typical critical stages of the manufacturing and formulation of biological drugs and radiopharmaceuticals
• can apply methods for analysis and quality control of raw materials for biological drugs and radiopharmaceuticals, as well as ready-to-use medicinal products, and assess how deviations affect the quality of the final products

General competence

The student

• can contribute to quality development in the manufacturing of medicinal products
• can contribute to the process of developing a medicinal product until the finished product has been marketed and meet the medical needs of society, at the national and international level, in a sustainable manner

The course provides an introduction to land use and transport planning from a sustainability perspective. Students are given an introduction to the Norwegian planning system, as well as to the history, theories and methods of land use planning. The framework for land use planning is explained in relation to the overriding guidelines (legislation, standards etc.), but also in relation to the desired qualities (value basis) to be incorporated in the planning. The transport system has consequences for all parts of society and affects the environment and people in the form of air quality, noise, climate change and traffic accidents. Land use, the transport network, transport committees, local climate, road, water, sewage and storm water infrastructure are strongly linked to sustainable development, and the course provides an overview of how they are related and describes strategies for sustainability. Compulsory participation in laboratory exercises (NovaPoint Areal or Focus Arealplanlegging and NovaPoint VA) as well as inspections and study trips.

For those who cannot participate in the organized study trips and examinations, it will be possible to conduct individual study trips and examinations in the Oslo area, by agreement with the course coordinator.

No requirements over and above the admission requirements.

After completing the course, the student is expected to have achieved the following learning outcomes defined in terms of knowledge, skills and general competence:

Knowledge

The student is familiar with:

• legislation, regulations, central and local government planning guidelines, guides and local government standards for drawing up plans and case processing of land-use plans
• planning and public participation processes, case processing of plans and the use of objections
• selected parts of the history of land use planning and planning theories
• environmental and planning ethics
• the relationship between urban structure and transport. The student is capable of explaining sustainable land use and transport solutions.

Skills

The student:

• is capable of preparing a zoning plan with pertaining zoning regulations and plan descriptions in accordance with the Ministry of the Environment's guidelines for zoning plans, and overriding guidelines
• is familiar with the principles for drawing up zoning plans using suitable software (NovaPoint Areal, Focus Arealplanlegging or similar) and pertaining technical plans for roads and water and sewage (plan drawings, longitudinal and cross-section drawings), and is capable of conducting impact assessments for area zoning plans and risk and vulnerability assessments for detailed zoning plans
• is capable of carrying out basic traffic technical calculations and analyses

General competence

The student is capable of:

• organising, planning and carrying out interdisciplinary studies, analyses and reports.
• describing political processes and decision-making processes for municipal land-use plans
• describing the principles for sustainable land use and transport development
• using interviews and literature studies as methods for producing surveys and reports

The following coursework is compulsory and must be approved before the student can sit the exam:

• participation in all compulsory inspections (up to 4 days)
• participation in laboratory training in the use of software (Fokus Areal or NovaPoint Areal, NovaPoint VA, and, if relevant. GIS) (10 hours)

1) Individual oral exam (50%)

2) Portfolio assessment subject to the following requirements (50%)

Four written assignments:

Part 1: Zoning plan

Part 2: Reports from study trips and inspections.

Part 3: Practical exercises in transport planning

Part 4: Individual in-depth report

A pass is required in all parts of the portfolio exam in order to be able to sit the exam in the subject.

Both parts of the exam must be awarded pass in order for the student to pass the course.

Exam part 1) The result of the exam cannot be appealed.

Exam part 2) The result of the exam can be appealed.

1) None.

2) All.

Pass/fail.